DIABETES CONTROL AND COMPLICATIONS TRIAL

糖尿病控制和并发症试验

• 批准号: 3550678
• 负责人: JOHN DUPRE
• 金额: $ 35.66万
• 依托单位: UNIVERSITY OF WESTERN ONTARIO
• 依托单位国家: 美国
• 财政年份: 1982
• 资助国家: 美国
• 起止时间: 1982-03-01 至 1994-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3550678
• 关键词: adolescence (12-20); adult human (21+); artificial endocrine pancreas; behavioral medicine; blood chemistry; blood glucose; blood lipid; cooperative study; diabetes education; diabetes mellitus therapy; diabetic angiopathy; diet therapy; drug administration rate /duration; drug delivery systems; endocrine disorder chemotherapy; epidemiology; fluorescein angiography; glycosylation; hemoglobin As; home health care; hormone therapy; human subject; human therapy evaluation; insulin; insulin dependent diabetes mellitus; kidney disorder diagnosis; longitudinal human study; medical complication; metabolism disorder diagnosis; nervous system disorder diagnosis; nutrition education; nutrition related tag; psychological tests; self care; therapy compliance; urinalysis

The goal is to demonstrate prospectively whether or not the course of microvascular complications in insulin-dependent diabetes mellitus can be modified by altered glycemic control. The major question addressed is whether significantly different mean levels of glycemia can be maintained in comparable groups of volunteers with IDDM and whether these will be associated with different rates of evolution of microangiopathy. The feasibility of recruitment and randomization of volunteers to standard and experimental treatments as defined, and of attainment of different target levels of glycemic control in two groups, was demonstrated with participation of this clinic, through periods of more than 1 year in phase II of the study. It is proposed that patients will continue to be recruited according to the specified eligibility criteria. After giving informed consent volunteers will be randomized to the standard treatment with one or two injections of insulin a day, or to an experimental treatment based on multiple daily infections or continuous subcutaneous infusion of insulin. Glycemic control will be assessed according to measurements of blood glucose and hemoglobin A1C. The protocol incorporates safeguards against the risks of the treatments and has been judged ethically acceptable. During phases I and II of the study the University of Western Ontario (UWO, Clinic 18) has developed the staff and facilities required for phase III. Strategies for ensuring successful recruitment, for maintenance of adherence to the protocol, and for recognition and minimization of intercurrent events, are outlined. The summation of data from all DCCT clinics will be used to test the question whether the attainable relative improvement in glycemic control resulting from the experimental treatment as defined can prevent or ameliorate microvascular complications of Type I diabetes.

目标是前瞻性地证明 胰岛素依赖性糖尿病的微血管并发症可能是 通过改变血糖控制的改变。 解决的主要问题是 是否可以维持平均水平的显着不同水平 在具有IDDM的可比志愿者群体中，这些是否会 与微血管病的进化速率不同。 这 招募和志愿者随机将标准和随机化的可行性 定义的实验处理和实现不同的目标 两组的血糖控制水平被证明 该诊所的参与度超过1年的期限 II研究。 建议患者将继续 根据指定的资格标准招募。 给予后 知情同意志愿者将被随机分配给标准治疗 每天一次或两次注射胰岛素，或进行实验 基于多种每日感染或连续皮下处理的治疗 输注胰岛素。 血糖控制将根据 血糖和血红蛋白A1c的测量。 协议 纳入防御治疗风险的保障措施，已经 在道德上可以接受。 在研究的第I和第二阶段期间 西安大略大学（UWO，诊所18）已经开发了员工， 第三阶段所需的设施。 确保成功的策略 招聘，维持遵守协议的遵守以及 概述了识别和最小化事件。 这 所有DCCT诊所的数据求和将用于测试这个问题 导致血糖控制的相对相对改善是否可实现 从定义的实验处理中可以预防或改善 I型糖尿病的微血管并发症。